Abstract Body (Do not enter title and authors here): BACKGROUND Despite progressively high morbidity and mortality rates associated with severe tricuspid regurgitation (TR), limited treatment options are available.
AIMS The single-arm, multicenter, prospective TRISTAR study(K-Clip Transcatheter Annuloplasty System in Tricuspid Regurgitation(TRISTAR) Early Feasibility Study) evaluated the 1-year outcomes of the novel transcatheter K-Clip reconstruction system in treating secondary TR.
METHODS Between May 2022 and October 2022, patients with ≥severe secondary TR at 11 centers, despite medication therapy, were deemed candidates for transcatheter tricuspid repair by the local Heart Team and a multidisciplinary screening committee.
RESULTS Ninety-six patients were enrolled(mean age 72.7±7.1 years, 60.4% female, mean TRISCORE 5.3±2.1). Technical success and procedural success were achieved in 97.9% and 93.8%. At 1 year, echocardiography showed average reductions of annular septolateral diameter by 11.3% (41.9mm vs. 37.1mm, p < 0.001) with increases in stroke volume(60.8±18.5mL vs 67.6±19.8mL, p < 0.001) and cardiac output(4.3±1.5 vs 5.3±2.0, p < 0.001). Tricuspid regurgitation was reduced to ≤moderate in 82.5% with ≥1-grade reduction in 97.7% and ≥2-grade reduction in 66.3%. Patients experienced significant clinical improvements in New York Heart Association (NYHA) functional class I/II (32.6% to 96.5%, p < 0.001). Six-minute walk test increased by 31.9m(304.3±81.2, p<0.001), and overall Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 7.6 points(66.7±16.89 vs 74.4±13.6, p<0.001). No cardiovascular mortality was reported while severe bleeding was reported in 5 patients. Kaplan-Meier estimated of survival and freedom from heart failure re-hospitalization were 97.8% and 95.1%, respectively.
CONCLUSIONS One-year experience using the K-Clip tricuspid annuloplasty system demonstrated high survival rates, low complications and durable improvements in TR reduction, functional status, and quality of life for patients with severe secondary TR.